Container for supplemental medication and method of using the same



Sept. 25, 1962 J. A. THORSTAD 3,055,367 CONTAINER FOR SUPPLEMENTALMEDICATION AND METHOD OF USING THE SAME Filed July 15, 1955 Zia;

James/4. 7/7oraiad IN V EN TOR.

3,055,367 CONTAINER FOR SUPPLEMENTAL MEDICATIQN AND MEET-T01) OlF UhlNGTHE SAME James A. Thorstad, Chicago, Ill., assignor to BaxterLaboratories, The. Filed July 13, 1955, Ser. No. 521,687 7 Claims. (Cl.128-272) This invention relates to a container for supplementalmedication and the method of using the same and, more particularly, to avial-type container adapted to add a medicament to a parenteral solutionbottle having its contents under a pressure less than atmospheric andthe combination thereof.

The application is a continuation-impart of my co- 1 pending applicationSerial No. 497,572 filed March 29, 1955, now abandoned.

In the past, the production of parenteral solutions has been limitedgenerally to those widely and frequently used in considerable quantity(i.e., glucose, saline, vitamins and the like). This limitation becomesmeaningful when one considers that it is uneconomical to provide orstock infrequently called-for parenteral solutions which are generallybulky (being upwards of 500 co. in volume), heavy and stored in fragileglass bottles. Another significant limitation on the types of parenteralsolutions produced results from the period between production and use sothat only relatively stable parenteral solutions are currently marketed.

Thus, when a physician feels that a patients condition indicates adistinctive parenteral regimen, he must either resort to thetime-consuming expedient of making a second and sometimes painfulvein-puncture or attempt to combine the distinctive medicine with thebasic parenteral solution. Since parenteral therapy should be carriedout under sterile conditions, it is apparent that any addition ofsupplemental medicine to the parenteral administration system shouldlikewise be performed as aseptically as possible. This appears all themore significant when one considers that parenteral solutions aregenerally produced with the liquid contents under vacuum so thatbreaking the vacuum seal gives the doctor or nurse performing theadministration a signal whereby he or she can ascertain that thesolution has remained uncontaminated. Additional procedures involvinghypodermic syringes may avert contamination but at the expense of timewhich is often a critical factor.

The container of my invention, when used in combination with aparenteral solution bottle, not only eliminates the need for theaforementioned second vein puncture but also achieves the addition ofsupplemental medication to the bottle under substantially asepticconditions without loss of time.

Essentially, my invention includes a separate container for thesupplemental medicine, this container being provided with a dispensingcap that permits its contents to be introduced into the vacuum-packedparenteral solution container prior to administration of the parenteralsolution itself.

My invention will be explained in conjunction with the accompanyingdrawing, in which FIG. 1 is an elevational view of the container forsupplemental medication of my invention in conjunction with a typicalparenteral solution container; FIG. 2 is an enlarged cross-sectionalview of a supplemental medication container of my invention containing aliquid medicament; and FIG. 3 is a view similar to FIG. 2; but showing amodified form of my invention adapted to contain a solid medicament.

Referring now to the drawing, and in particular to FIG. 1, the numeral16 designates the container for supplemental medication. The numeral 1 1generally desig- 3,55,357 Patented Sept. 25, 1962 nates a typicalparenteral solution bottle with its contents under vacuum. Bottle 11 isprovided with a rubber stopper 12 mounted in its neck and provided withan annular flange portion 12a to prevent stopper 12 from being drawninto bottle 11 by virtue of the vacuum existing therein. Extendingthrough stopper 12 is liquid discharge passage 13 which is sealed untiluse by frangible diaphragm 14a, provided by rubber disc 14 extendingacross the top surface of stopper r12 and being generally coextensivetherewith. Both disc 14 and stopper 12 are further secured to the neckof bottle 11 by apertured metal cap 15 which is rolled on the neck andheld in position by neck bead Ila.

Not shown as extending through stopper 12; is a second passage alsoclosed by disc 14 at the vacuum dimple indicated as 14b. Mounted in thispassage and extending into bottle 11 is air tube 16. In its dischargingcondition, bottle 11 is mounted in mouth-downward fashion by means of asuspension device consisting of bail l7 and band 18 so that air tube 16permits air to enter container 11 through a puncture in diaphragm 14b toreplace liquid 19 discharged through passage 13.

Rigid container '10 can be best seen by referring to FIG. 2, in whichthe numeral 29 designates a glass vial provided with one open end 20a.The external wall of vial 20 is threaded as at 2012 part way back fromopen end 20a. Threadably mounted on vial 26 is dispensing cap 21.Dispensing cap 21 is provided with female threads 21a which engagecontainer threads Ztlb for mounting of dispensing cap 21. The end ofdispensing cap 21, remote from the threaded portion, is pointed, as at22, to permit ready puncture of diaphragm 14a of bottle 11 and is of anouter diameter so as to fit in air-tight engagement with the walls ofpassage 13 when inserted therein as shown in FIG. 1. Protecting theinserted portion of dispensing cap 21, and particularly point 22, isprotector sleeve 23, which is mounted over cap 21. Inserted between cap21 and the open end 20a of vial 2t), and also closing off the open endthereof, is rubber diaphragm 24. Diaphragm 24 is held in place by thecooperation of shoulder portion 21b of cap 21 and lip portion of theopen end Ztla of vial 20. Thus, diaphragm 24- also acts as a gasketbetween dispensing cap 21 and vial Ztl.

Diaphragm 24 is provided with a vacuum-operable valve 25 which, in thepreferred embodiment, is a small aperture which substantially preventsoutflow of liquid from vial 20 upon inversion except under theimposition of an external vacuum. Thus, it is possible to invertcontainer 20, which has been previously charged with supplementalmedicine 26, even when protector sleeve 22 has been removed, withouthaving medicine 26 flow out of container 20.

As noted above, FIG. 3 depicts a modified form of my invention usefulfor the addition of a solid medicament to parenteral solution bottles.The various elements of FIG. 3, being substantially identical to thoseof FIG. 2, are designated by like numerals except for the addition of aprime The container 10' shown in FIG. 3 differs from container 1d ofFIG. 2 in the provision of a substantially larger aperture 25 indiaphragm 24, so that diaphragm 24 serves primarily as a gasket.

Operation In the operation of my invention, a container holding thedesired supplemental medicament 26 is provided for a patient to whomparenteral therapy is about to' be administered. The parenteral solutioncontainer is provided with its contents partially evacuated but with thevacuum seal provided by disc 14 still intact. Protector sleeve 23 isremoved from the tip of dispensing cap 21, and vial Ztl is inverted andinserted through frangible diaphragm 14a of bottle 11, substantially asshown in FIG. 1.

Then, under the influence of vacuum existing above liquid 19 liquidmedicine 26 is drawn through capillary 25 into bottle 11. It isimportant to note that the structure of my additive container willoperate successfully with any parenteral solution container having itscontents under vacuum and provided with a puncturable closure sealingthe container. The embodiment of my invention shown in FIG. 2 is alsouseful in connection with other types of puncturable closures as wherediaphragm 14a is provided integral with stopper 12. A modification ofdispensing cap 21 for use with closures puncturable only by a sharpercap portion than that shown in FIG. 2 involves the provision of a cap 21of a size and construction approximating a hypodermic needle. By using acap of this modified nature not only can the same be inserted readilythrough greater thicknesses of stopper but diaphragm 24 can also beeliminated. Thus, the small bore of a needle substituted for the plasticmolded cap 21 shown in FIG. 2 substantially prevents outflow of fluidupon inversion of vial 20 except when it is under the influence of anexternal vacuum. I have found that a diaphragm opening 25 of a diameterof 0.020" provides this desired valve operation. This size openingcorresponds to the bore of a 21 gauge needle. In this way theconstricted passage communicating between vial 20 and bottle 11 isachieved without the use of diaphragm 24, the constriction thereby beingintegral with cap 21.

In considering FIG. 2, it is seen that the supplemental medicine 26occupies only a portion of vial 20 so that a substantial air spaceexists. Investigation has shown that this air space is essential forsubstantially complete discharge of the contents of vial 2%) into bottle11. Failure to provide suitable air space in vial 20 permits by partialdischarge of its contents the building up of a vacuum within vial 20approximately equal to that existing in bottle 11. Thus, it isimpossible to discharge the last portions of medicine 26 from vial 20since under such equilibrium conditions the internal pressure in vial 20is not greater than the external pressure, i.e., that in bottle 11.Complete discharge of all medicine is considered essential since themedicine is accurately measured for prescription by a physician toachieve a desired parenteral regimen. An insulficient amount maypreclude the achieving of the desired skeletal muscle relaxant eifect,as in the case of succinylcholine chloride, or an excess may bedangerous.

For example, when vial 20 has an internal capacity of 10 ml. and isequipped with a discharge cap 21 having a portion of its dischargepassage constricted to an opening of amout 0.020" diameter, it was foundthat a newly produced liter solution bottle 11 would only fully emptyvial 20 when it was charged with about 5 ml. of a supplemental medicinesuch as succinylcholine chloride. The vacuum existing in bottle 11 wasof the order of 16" Hg. Bottles standing for prolonged periods beforeuse as is not unusual in hospital operation, sometimes lose part oftheir vacuum. Under such conditions, as where the bottle vacuum wasreduced to about Hg, a vial of 10 ml. capacity changed with only about 3ml. could be substantially emptied.

In adding the solid contents of container 10' of FIG. 3 to a parenteralsolution bottle 11 having its contents under vacuum, the procedureoutlined above with respect to liquid-containing container 10 of FIG. 2is followed.

Thus it is to be noted that the possibility of contamination of theparenteral solution is relatively slight, since only the puncture tip ofthe additive container is exposed to the atmosphere for a few secondsand the vacuum condition within the parenteral solution container ispreserved by the air-tight engagement of the puncture tip of cap 21 withthe walls of passage 13.

Another expedient to effect substantially complete discharge of medicinefrom vial 20 is to construct vial 20 so that its internal volume isdiminished as medicine is drawn therefrom under the influence of thevacuum in bottle 11. Thus, no reduced pressure space is present topermit reaching the pressure equilibrium conditions that preventdischarge of the last portions of medicine.

The foregoing detailed description has been given for clearness ofunderstanding only, and no unnecessary limitations are to be inferredtherefrom.

I claim:

1. In parenteral solution equipment, a rigid vial containing a medicinesuitable for addition to a parenteral solution container, said vialhaving an open mouth, puncturing discharge cap means mounted on saidvial to partially close the mouth thereof and providing a dischargepassage for said medicine, said passage being equipped with constructionmeans restricting gravity out flow of said medicine except when thedischarge end of said cap means is subjected to a pressure less thanatmospheric, and a dispensing parenteral solution container having itscontents sealed under a pressure less than atmospheric, said dispensingcontainer being provided with an air tube-equipped, puncturableresilient stopper, the said vial being positioned above said containerwith the discharge cap means of said vial being inserted through saidstopper into communication with the interior of said dispensingcontainer and thereby having the said discharge end thereof subjected toa pressure less than atmospheric, said medicine only partially fillingthe said vial prior to the insertion of said discharge cap means throughsaid stopper, the remaining interior volume of said vial constituting anair space effective to force said medicine into said container.

2. The structure of claim 1 in which said constriction means comprises adiaphragm equipped with a capillarysized opening extending therethrough.

3. In parenteral solution equipment, a rigid vial for liquid medicinehaving an open mouth, a puncturing discharge cap mounted on said vial toenclose the mouth thereof and equipped with a discharge passage for saidliquid medicine, means constricting said passage to permit liquiddischarge therethrough only when the discharge end of said cap is at apressure less than atmospheric, and a rigid dispensing parenteralsolution container having its contents sealed under a pressure less thanatmospheric, said container being equipped with an air tubeequippedresilient puncturable stopper, said vial being above said container withthe discharge cap portion of said vial being inserted through saidstopper into said container, said vial prior to insertion being onlypartially filled with medicine and with atmospheric air occupying theremaining vial interior so that greater pressure is exerted on the lastliquid in said vial by the air therein than by the air above the liquidin said parenteral solution container.

4. The structure of claim 3 in which the said constricting meanscomprises a diaphragm mounted across the mouth of said vial and equippedwith an aperture sized to prevent gravity outflow of said liquid exceptwhen said discharge end is under a pressure less than atmospheric.

5. An additive vial for a parenteral solution container under vacuum,comprising a medicine vial open at one end, medicine only partiallyfilling said vial, puncturing discharge cap means partially closing saidopen end, and constriction means associated with said cap meanspermitting medicine to flow therethrough only under the imposition of anexternal vacuum, the vial interior portion not filled with said medicinehaving atmospheric pressure therein effective to force said medicinefrom said vial when the said cap means is subjected to subatmosphericpressure.

6. An additive vial for a parenteral solution container, comprising aliquid medicament container open at one end, liquid in said containeronly partially filling the same with the remainder constituting an airspace at atmospheric pressure, a diaphragm provided with avacuum-operable valve closing said open end, and discharge cap meansmounted on said container for enclosing said diaphragm.

7. A vial containing a supplemental liquid medicine for a parenteralsolution container, comprising a glass vial open at one end, liquid insaid vial only partially filling the same with the remainderconstituting an air space under atmospheric pressure, discharge capmeans mounted on said vial .and enclosing said open end, and a diaphragmmounted between said cap means and said container also closing said openend, said diaphragm having an aperture therein, said diaphragmpermitting flow of medicine therethrough only upon application of avacuum to the discharge end of said discharge cap 15 means.

References Cited in the file of this patent UNITED STATES PATENTSChapman Oct. 9, Mulford et al. May 28, Rausch Jan. 1, Lockhardt Nov. 22,Lockhart Dec. 13, Persson Dec. 11,

FOREIGN PATENTS France Nov. 24, Germany Apr. 2, Switzerland Mar. 1,Italy Feb. 26,

